| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00237-1 |
| Product Name/Description |
HemoCue Glucose 201 RT Microcuvettes (used with HemoCue Glucose 201 RT and HemoCue Glucose 201 RT DM analysers). An in vitro diagnostic medical device (IVD)
Product Code: 114701
Batch Numbers: 1506998, 1507909, 1508920, 1405990, 1407901, 1410921, 1411931, 1501939, 1501950, 1504972, 1506995
ARTG Number: 222660 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
HemoCue has recently become aware of a production related problem that affects HemoCue Glucose 201RT Microcuvettes. During an internal investigation a minor deviation was found, which may cause the microcuvettes to not perform as intended. There was an incorrect position for the sleigh in the final punch which affects the grouping of cuvettes with respect to measuring level. The accuracy of glucose levels below 4.1mmol/L may deviate by up to +0.9 mmol/L, resulting in falsely high results. There is also a low possibility that results in the range of 6.6-8.8 mmol/L may be falsely elevated.
No harm to patients has been reported. However, there is a risk that a false high result for low glucose levels could lead to delayed or missed diagnosis of hypoglycaemia, as clinical symptoms are not always present. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer is advising users that the affected product can continue to be used in adults. The affected lots should not be used in neonates or infants. Users should verify low or marginal results via another method. |
| Contact Information |
1800 247 254 - HemoCue |